Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of nCRT for Locally Advanced ESCC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Diagnostic Test: Magnetic resonance imaging (MRI)Diagnostic Test: 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT)Diagnostic Test: Blood and urine metabolic biomarker
- Registration Number
- NCT04759235
- Lead Sponsor
- RenJi Hospital
- Brief Summary
Esophageal cancer (EC) is the seventh most frequently diagnosed cancers and the sixth leading causes of cancer death worldwide . It is one of the most common malignancy in China, with the third highest morbidity and mortality rate. More than 90% of patients with EC in China have esophageal squamous cell carcinoma (ESCC). Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is currently widely used strategy for locally advanced surgical EC.
At present, conventional imaging methods have certain defects (focus only on the volume change) in the evaluation of the efficacy of nCRT. Whereas functional imaging can more comprehensively reflect the biological and microstructural characterization of tumors. The changes of these aspects of tumors can be observed earlier than volumetric changes of tumors.
The normal metabolism of the body is the basis for ensuring life activities. Due to the increased energy demand and proliferation of tumor tissue in patients with cancer, the metabolism of patients is different from that of normal person. Thus, the metabolic alterations seen in cancer cells have emerged as one of the hallmarks of cancer. Previous metabolomic studies have demonstrated various metabolic alterations in patients with ESCC. Many metabolites have been found to be promising diagnostic, staging or prognostic biomarkers for ESCC. However, there are few studies on metabolic markers on the chemoradiation sensitivity of esophageal cancer.
Therefore, the aim of the present study is to evaluate the value of functional imaging parameters and metabolic markers in assessing and predicting pathological response in patients who underwent nCRT for ESCC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 118
- Pathologically confirmed esophageal squamous cell carcinoma；
- AJCC 7th edition staging T3-T4a or N+；
- No radiotherapy or chemotherapy in the past；
- 18-75 years old；
- Hematology, biochemical and organ function indicators meet the following requirements: 1) White blood cells ≥ 3.0 x109/ L; 2)neutrophil cells ≥ 1.5 x109/ L; 3) Platelet count ≥85 x109/L; 4) Hemoglobin ≥90 g/L; 5) Total bilirubin ≤1.5 times normal value; 6) ALT≤ 1.5 x normal value; AST ≤1.5 times the normal value; 7) Serum creatinine ≤1.5 times the normal value, and creatinine clearance rate (Ccr) ≥60ml/min (Cockcroft-Gault);
- ECOG score 0-1 points;
- Able to eat a semi-liquid diet；
- sign an informed consent.
- Have received radiotherapy or systemic chemotherapy;
- During pregnancy or lactation;
- Uncontrollable serious medical diseases;
- Unable to sign informed consent;
- With distant metastasis;
- Suffering from the second type of malignant tumor (except skin squamous cell carcinoma and carcinoma in situ of other organs) within the past 5 years；
- Those who cannot receive MRI examination;
- Chemotherapy drugs or contrast agents Allergic.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description neoadjuvant chemoradiotherapy of local advanced ESCC Magnetic resonance imaging (MRI) All the patients receive paclitaxel/cisplatin chemotherapy and concurrent radiotherapy. Each patient receives radiation of 41.4 Gy / 23 fractions complied by intensity modulated radiotherapy or volumetric modulated arc therapy. Patients without disease progression after nCRT will be scheduled for surgery and patients with disease progression (PD) will continue to receive chemoradiation or additional treatments. Surgery will be performed 6 to 8 weeks after completion of chemoradiotherapy. neoadjuvant chemoradiotherapy of local advanced ESCC 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) All the patients receive paclitaxel/cisplatin chemotherapy and concurrent radiotherapy. Each patient receives radiation of 41.4 Gy / 23 fractions complied by intensity modulated radiotherapy or volumetric modulated arc therapy. Patients without disease progression after nCRT will be scheduled for surgery and patients with disease progression (PD) will continue to receive chemoradiation or additional treatments. Surgery will be performed 6 to 8 weeks after completion of chemoradiotherapy. neoadjuvant chemoradiotherapy of local advanced ESCC Blood and urine metabolic biomarker All the patients receive paclitaxel/cisplatin chemotherapy and concurrent radiotherapy. Each patient receives radiation of 41.4 Gy / 23 fractions complied by intensity modulated radiotherapy or volumetric modulated arc therapy. Patients without disease progression after nCRT will be scheduled for surgery and patients with disease progression (PD) will continue to receive chemoradiation or additional treatments. Surgery will be performed 6 to 8 weeks after completion of chemoradiotherapy.
- Primary Outcome Measures
Name Time Method Histopathologic response Based on resection specimen (surgery 6-8 weeks after finishing nCRT) Histopathologic response of the primary tumor to nCRT according to the tumor regression grade (TRG) scale as determined by expert pathologist. TRG 1(pCR): no residual viable tumor cells, pathologic complete response TRG 2: rare residual cancer cells TRG 3: predominant fibrosis with increased number of residual cancer cells TRG 4: residual cancer outgrowing fibrosis or no regressive change
∆ADC within 2 weeks before the start of nCRT，2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT change of apparent diffusion coefficient in DW-MRI and difference between pCR group and non-pCR group
∆TLG within 2 weeks before the start of nCRT，2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT change of total lesion glycolysis in PET/CT and difference between pCR group and non-pCR group
change of metabolites within 2 weeks before the start of nCRT and 4-6 weeks after the completion of nCRT change of metabolites after chemoradiotherapy and differences between pCR group and non-pCR group
- Secondary Outcome Measures
Name Time Method Overall survival Up to 5-year follow-up time to die or follow-up deadline
Disease-free survival Up to 5-year follow-up time to locoregional or distal recurrence
Trial Locations
- Locations (1)
Renji Hospital
🇨🇳Shanghai, Shanghai, China